|Study title||Assessment of care augmentation by location-linked messaging in amyotrophic lateral sclerosis with respiratory impairment compared with current standard care|
|UK Chief Investigator||Professor Ammar Al-Chalabi|
|Research summary||Until recently, the onset of diaphragmatic weakness in amyotrophic lateral sclerosis (ALS) had no effective treatment other than palliation by opiates and similar drugs. Use of respiratory support through non-invasive ventilation is now widespread, allowing relief from symptoms related to type 2 respiratory failure such as severe breathlessness, loss of appetite, headache and excessive daytime sleepiness. A consequence of type 2 neuromuscular respiratory failure is elevation of blood carbon dioxide levels tolerated by adaptation of physiologic control systems. Since elevation of blood carbon dioxide is the usual trigger for respiration, tolerance means an alternative trigger is used, that of a low blood oxygen. The treatment of someone with chronic type 2 respiratory failure with oxygen therefore negates the only remaining trigger for breathing and results in drowsiness followed by death.
A common treatment response by emergency services to anyone in extremis, and especially those with breathlessness, is the use of high dose oxygen delivered by mask. Individuals with ALS in type 2 respiratory failure may suffer reversible complications such as pneumonia, and be inappropriately prescribed high dose oxygen by emergency services. Alternatively, they may be in the end stages of ALS, when an emergency room is not a desirable or appropriate location for end-of-life care, and a better response would be use of community palliative care services.
In this study a custom-designed location detecting smartphone app will be used to send predefined text messages to specialist individuals on arrival of a patient with ALS in an A&E department. The specialist will provide intervention advice and education to A&E staff.This will be compared with patients receiving usual care.In addition, feasibility and tolerability of smartphone technology use in ALS patients will be explored and measured including different types of disease progression data, collected with patient agreement
|Inclusion/exclusion criteria||Inclusion Criteria:
i. Diagnosis of ALS ii. Subjects of either sex aged 18 years or over iii. Stage 3 or 4 ALS iv. Capable of understanding the information given and giving fully informed consent prior to any study specific procedures. v. Willing for the study team to contact patient’s GP about the study
i. Patients at high risk of A&E admission for respiratory care unrelated to ALS because of underlying respiratory disease ii. Any patient involved in another study in which an intervention is designed to improve diaphragmatic function. iii. Refusal of palliative care iv. Impaired cognition as judged by clinician
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
|Current status||Active – recruiting|
|Locations||King's College Hospital, London|
|Recruitment group(s)||Patients with MND|
|Recruitment target(s)||20 patients.|
|Key dates||Study start date: 22 June 2017
Target study completion date: July 2018
|Sponsor||King's College London|
|Intervention (if applicable)||The Call-Me smart phone app|
|Phase (if applicable)||N/A|
|Outcome measures||Primary outcome measures: The number of inappropriate hospital admissions|
|Publications / Results reports|
|Participant Information Sheet|